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Senior Director, Compliance (Technical Operations)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

High Level Description

This position will be located at BioMarin’s San Rafael, CA Headquarters and will report to the Vice President, Technical Operations Compliance.  You will serve as a key member of the TOPs Compliance leadership team; and be responsible for helping to orchestrate a high-performance environment as it relates to strategic planning and execution, demand management, collaboration, financial planning and managing communication across the Global Compliance and Ethics and client organizations.  You will provide direction to maintain an acceptable level of compliance-risk and be responsible for fostering a culture of compliance and continuous improvement.

Operational Accountability

Leadership

  • Facilitate alignment of a TOPs Compliance strategy road map with corporate and TOPs strategies and strategic initiatives. Assist with strategy execution against the road map.
  • Provide leadership in defining, mapping and documenting key programs, projects, and priorities; partnering closely with the Audit, Proactive Compliance and Distribution Compliance functions.
  • Actively represent the TOPs Compliance organization on multiple forums
  • Work with client group leaders to proactively identify, communicate/escalate and mitigate material compliance risk
  • Drive continuous compliance improvement for the organization across organizational boundaries and formal lines of reporting
  • Globally responsible for compliance to regulatory standards, translating information from Regulatory Intelligence into practical, deploy-able solutions by collaborating with all stakeholders
  • Interface with stakeholders in a consultative fashion to influence compliance in operations
  • Represent Compliance during issue management scenarios
  • Actively participate in designing and effecting the Compliance strategy
  • Aid in developing Compliance staff to realize their full potential and achieve peak performance
  • Support Global Compliance and Ethics succession planning efforts

Global Compliance Program

  • Serve as a liaison between client groups and Compliance analyzing compliance risks; mitigation's and supporting strategic initiatives
  • Facilitate and attend Compliance leadership meetings - assist with tracking, prioritization and follow-up with attendees to track deliverables.
  • Actively represent Compliance in the TOPs Extended Leadership team, CMC teams and other cross-functional team forums
  • Work with the audit, distribution/supply chain compliance and proactive compliance functions to ensure best in class compliance programs and integration with related business units
  • Partner with foreign offices to ensure compliance standards are understood and achieved
  • Third party MAH compliance program management
  • Lead the Compliance Update forum for TOPs executives
  • Contribute to the quarterly Board of Director Compliance updates; ensure report and presentation are to a high standard and on time
  • Establish and report effective KPIs to help identify key compliance trends and issues
  • Support due diligence related to potential acquisitions ensuring compliance and data integrity requirements are appropriately assessed and considered
  • Engage proactively with stakeholders to build a progressive and integrated GxP Compliance function
  • Maintain expert level knowledge of compliance requirements and industry trends
  • All staff are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first-time performance
  • Provide communications plan and supporting as reports, presentations and internal communications
  • Up to 15% travel
  • Other duties as assigned

Experience:

  • 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • 10+ years of prior management experience
  • Excellent interpersonal and communications skill
  • Strong results-driven person combined with deep strategic and program leadership
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple projects efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and solve shared problems
  • Demonstrates in-depth understanding and application of cGxP principles, concepts, practices and standards
  • Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma
  • Prior experience with a combination of Quality Assurance/Control, Compliance, Regulatory Affairs and/or GxP project management

Education:

  • BA/BS in life sciences or related field
  • Advanced degree desirable but not required
  • Six Sigma or other quality tools training desired
  • Other continuing education initiatives or relevant industry or compliance certifications

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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